1. Technical Field
This document relates to devices and methods for monitoring and maintaining the temperature of medical reservoirs while maintaining a secure chain of custody and log of sample or product access. For example, this document relates to devices and methods for monitoring and regulating the temperature of blood, cerebrospinal fluid, or bone marrow in tubes or vials, vaccines in ampoules or bottles, and/or biological pharmaceutical products in boxes as well as the presence of it in the device and whether it has been removed.
2. Background Information
The Center for Disease Control reports that $300 million dollars was wasted in 2014 due to the improper storage and regulation of temperature for vaccines. If these vaccines and other biomedical samples (such as bone marrow, cerebrospinal fluid, or blood) as well as biomedical products (such as biological or biosimilar pharmaceutical products) freeze or get too warm, they can be ruined or lose potency and efficacy. In addition many samples need to be kept frozen while in storage and in transit. In addition, when phlebotomy tubes are drawn from patients that contain blood, certain clinical diagnostic tests for cryoglobulinemia or complement deficit mandate that the tubes must be kept at body temperature (37 degrees Celsius) or a life threatening diagnosis can be missed. Consequently, rigorous control of biomedical sample and product storage temperatures, and verification of the temperatures to which blood samples have been exposed is advantageous. In addition, having a more reliable and traceable chain of custody for security purposes to prevent tampering and/or the introduction of counterfeit products for these samples and products is advantageous. In addition, it is advantageous if an electronic log can be kept for temperature deviations, changes in location, and whether the sample or product has been accessed. It is also advantageous if all these separate features could be communicated in real-time to the internet and if all these features could be combined into a small, thin, conformable device to favor space constraints.